NCT01715415

A Study to Evaluate Chronic Hepatitis C Infection in Treatment Experienced Adults

A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of ABT450/Ritonavir/ABT-267 (ABT-450/r/ABT-267) and ABT-333 Co-administered With Ribavirin (RBV) in Treatment-Experienced Adults With Genotype 1 Chronic Hepatitis C Virus (HCV) Infection (SAPPHIRE-II)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 395 (actual)
• Sponsor: AbbVie (prior sponsor, Abbott) · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the safety and efficacy of ABT-450, ritonavir and ABT-267 (ABT-450/r/ABT-267; ABT-267 also known as ombitasvir) and ABT-333 (also known as dasabuvir) co-administered with ribavirin (RBV) in hepatitis C virus genotype 1 infected treatment-experienced adults.

Conditions

• Chronic Hepatitis C Infection

Interventions

Type	Name	Description
DRUG	ABT-450/r/ABT-267, ABT-333	Tablet; ABT-450 coformulated with ritonavir and ABT-267, ABT-333 tablet
DRUG	Ribavirin	Capsule (double-blind treatment period), tablet (open-label treatment period)
DRUG	Placebo for ABT-450/r/ABT-267	Tablet
DRUG	Placebo for ABT-333	Tablet
DRUG	Placebo for ribavirin	Capsule

Timeline

• Start date: 2012-11-01
• Primary completion: 2013-11-01
• Completion: 2014-10-01
• First posted: 2012-10-29
• Last updated: 2021-08-02
• Results posted: 2015-01-06